NCT00513305

Cytarabine in Combination With Arsenic Trioxide vs. Cytarabine Alone in Elderly Patients With Acute Myeloid Leukemia

An Open-Label, Randomized Study of Low-Dose Cytarabine in Combination With Arsenic Trioxide Compared With Low-Dose Cytarabine Alone for the Treatment of Elderly Patients With Acute Myeloid Leukemia

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 67 (actual)
• Sponsor: Cephalon · Industry
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to determine whether low-dose cytarabine in combination with arsenic trioxide is more effective than low-dose cytarabine alone in achieving complete remission in elderly patients (≥60 years of age) with acute myeloid leukemia.

Conditions

• Acute Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	Arsenic trioxide	Arsenic trioxide will be administered intravenously (iv) at a dose of 0.25 mg/kg.
DRUG	Low-dose cytarabine alone	Cytarabine will be administered at a dose of 10 mg/m\^2 subcutaneously (sc) twice a day (bid).

Timeline

• Start date: 2007-10-01
• Primary completion: 2009-07-01
• Completion: 2009-12-01
• First posted: 2007-08-08
• Last updated: 2012-08-01
• Results posted: 2011-03-29

Locations

12 sites across 2 countries: United States, Canada